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Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2024-02-06 and last amended on 2023-11-24. Previous Versions

PART DVitamins, Minerals and Amino Acids (continued)

DIVISION 3Addition of Vitamins, Mineral Nutrients or Amino Acids to Foods

  •  (1) In this Division, the expressions vitamin and mineral nutrient have the same meaning as in Divisions 1 and 2.

  • (2) This Division applies only in respect of foods that are represented as containing a vitamin, mineral nutrient or amino acid for use in human nutrition.

  • SOR/88-559, s. 35
  •  (1) Subject to section D.03.003, no person shall sell a food, other than a supplemented food, to which a vitamin, mineral nutrient or amino acid has been added unless the food is listed in Column I of the Table to this section and the vitamin, mineral nutrient or amino acid, as the case may be, is listed opposite that food in Column II.

  • (2) No milk or milk product or derivative listed in Column I of the Table to this section applies to the lacteal secretion obtained from the mammary gland of any animal other than a cow, genus Bos, or a product or derivative of such secretion unless that animal is identified therein.

    TABLE

    Column IColumn II
    FoodVitamin, Mineral Nutrient or Amino Acid
    1Breakfast cerealsThiamine, niacin, vitamin B6, folic acid, pantothenic acid, magnesium, iron and zinc.
    2Fruit nectars, vegetable drinks, bases and mixes for vegetable drinks and a mixture of vegetable juicesVitamin C.
    2.1Fruit flavoured drinks that meet all the requirements of section B.11.150Vitamin C, folic acid, thiamine, iron, potassium.
    2.2Bases, concentrates and mixes that are used for making fruit flavoured drinks and that meet all the requirements of section B.11.151Vitamin C, folic acid, thiamine, iron, potassium.
    3Infant cereal productsThiamine, riboflavin, niacin or niacinamide, calcium, phosphorus, iron, iodine.
    4Margarine and other similar substitutes for butterVitamin A, Vitamin D, alpha-tocopherol
    5Alimentary pastesThiamine, riboflavin, niacin or niacinamide, folic acid, pantothenic acid, vitamin B6, iron, magnesium
    6Human milk fortifiers, infant formulas and formulated liquid diets
    • Amino acids — alanine, arginine, aspartic acid, cystine, glutamic acid, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine;
    • Minerals — calcium, chloride, chromium, copper, iodide, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc;
    • Vitamins — alpha-tocopherol, biotin, choline, d-pantothenic acid, folic acid, niacin, riboflavin, thiamin, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K.
    6.1Foods represented for use in a very low energy diet
    • Vitamins — alpha-tocopherol, biotin, d-pantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K
    • Minerals — calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc
    7Flavoured beverage mixes and bases recommended for addition to milkVitamin A, thiamine, niacin or niacinamide, vitamin C, iron.
    8Simulated meat products, simulated poultry meat products, meat product extenders and poultry product extendersThiamine, riboflavin, niacin, pyridoxine, d-pantothenic acid, folic acid, vitamin B12, iron, magnesium, potassium, zinc, copper, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine.
    9Meal replacements and nutritional supplements
    • Vitamins — alpha-tocopherol, biotin, d-pantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D
    • Minerals — calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc
    9.1Ready breakfast, instant breakfast and other similar breakfast replacement foods however describedVitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin C, iron
    10Condensed milk, milk, milk powder, sterilized milk, (naming the flavour) milkVitamin D.
    11Skim milk with added milk solids, partly skimmed milk with added milk solids, (naming the flavour) skim milk, (naming the flavour) partly skimmed milk, (naming the flavour) skim milk with added milk solids, (naming the flavour) partly skimmed milk with added milk solids, skim milk, partly skimmed milk, skim milk powderVitamin A, vitamin D.
    12Evaporated milkVitamin C, vitamin D.
    13Evaporated skim milk, concentrated skim milk, evaporated partly skimmed milk, concentrated partly skimmed milkVitamin A, vitamin C, vitamin D.
    14Apple juice, reconstituted apple juice, grape juice, reconstituted grape juice, pineapple juice, reconstituted pineapple juice, apple and (naming the fruit) juice as described in section B.11.132, concentrated fruit juice except frozen concentrated orange juiceVitamin C.
    15Flour, White Flour, Enriched Flour or Enriched White FlourThiamine, riboflavin, niacin, vitamin B6, folic acid, d-pantothenic acid, calcium, iron, magnesium.
    16[Repealed, SOR/94-689, s. 2]
    17Table salt, table salt substitutesIodine.
    18Dehydrated potatoesVitamin C.
    19Products simulating whole eggVitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin B6, d-pantothenic acid, folic acid, vitamin B12, alphatocopherol, calcium, iron, zinc, potassium.
    20[Repealed, SOR/90-830, s. 11]
    21Goat’s milk, goat’s milk powderVitamin D
    22Partly skimmed goat’s milk, skimmed goat’s milk, partly skimmed goat’s milk powder, skimmed goat’s milk powderVitamins A and D
    23Evaporated goat’s milkVitamins C, D, folic acid
    24Evaporated partly skimmed goat’s milk, evaporated skimmed goat’s milkVitamins A, C, D, folic acid
    25Pre-cooked rice as defined in subsection B.13.010.1(1)Thiamine, niacin, vitamin B6, folic acid, pantothenic acid, iron
    26Mineral water, spring water, water in sealed containers, prepackaged iceFluorine
    27Liquid whole egg, dried whole egg, frozen whole egg, liquid yolk, dried yolk, frozen yolk, liquid egg-white, (liquid albumen), dried egg-white (dried albumen), frozen egg-white (frozen albumen), liquid whole egg mix, dried whole egg mix, frozen whole egg mix, liquid yolk mix, dried yolk mix, frozen yolk mixVitamin A, Vitamin D, Vitamin E, thiamine, riboflavin, niacin, vitamin B6, folacin, vitamin B12, pantothenic acid, calcium, phosphorus, magnesium, potassium, iron, zinc
  • SOR/78-64, s. 8
  • SOR/78-403, s. 29
  • SOR/78-478, s. 3
  • SOR/78-637, s. 11(E)
  • SOR/78-698, s. 10
  • SOR/79-6, s. 1
  • SOR/81-60, s. 14
  • SOR/83-858, s. 2
  • SOR/84-300, s. 62
  • SOR/85-623, s. 4
  • SOR/86-320, s. 2
  • SOR/87-640, s. 10
  • SOR/88-559, s. 36
  • SOR/89-145, s. 3
  • SOR/89-198, s. 18
  • SOR/90-830, s. 11
  • SOR/94-35, s. 5
  • SOR/94-689, s. 2
  • SOR/95-474, s. 6
  • SOR/96-259, s. 8
  • SOR/2010-143, s. 39(E)
  • SOR/2021-57, s. 24
  • SOR/2022-169, s. 27

 Section D.03.002 does not apply to a food, other than a supplemented food, if all of the following conditions are met:

  • (a) the food is

    • (i) a gluten-free food referred to in paragraph B.24.003(1)(g), or

    • (ii) represented for a special dietary use referred to in paragraph B.24.003(1)(h) or (i);

  • (b) no standard is prescribed in these Regulations for the food; and

  • (c) the food is not advertised.

DIVISION 4[Repealed, SOR/2003-196, s. 105]

DIVISION 5Minerals in Drugs

 [Repealed, SOR/2003-196, s. 106]

  •  (1) Subject to subsection (2), no person shall sell a drug containing fluorine if the largest recommended daily dosage of that drug as shown on the label thereof would, if consumed by a person, result in a daily intake by that person of more than one milligram of fluoride ion.

  • (2) Subsection (1) does not apply to a drug sold by prescription.

  • SOR/81-196, s. 2

 Where a drug contains fluorine, both the inner and outer labels of the drug shall carry a cautionary statement that, if the drug is used in an area where the drinking water has a natural fluorine content in excess of 0.7 parts of fluoride ion per million parts of water or is artificially fluoridated, mottling of the tooth enamel of a user of the drug may result.

 [Repealed, SOR/2003-196, s. 107]

PART ECyclamate Sweeteners

[
  • SOR/2016-74, s. 11
]
  •  (1) In this Part, cyclamate sweetener means any of the following substances sold as a sweetener:

    • (a) cyclohexyl sulfamic acid or any of its salts; and

    • (b) any substance containing cyclohexyl sulfamic acid or any of its salts.

  • (2) Part B does not apply to any cyclamate sweetener.

  • SOR/78-422, s. 4
  • SOR/2016-74, s. 12

Sale

 No person shall sell a cyclamate sweetener that is not labelled as required by this Part.

  • SOR/78-422, s. 4
  • SOR/2016-74, s. 13

Advertising

 No person shall, in advertising a cyclamate sweetener to the general public, make any representation other than with respect to the name, price and quantity of the sweetener.

  • SOR/78-422, s. 4
  • SOR/2016-74, s. 14

Labelling

 Every cyclamate sweetener shall be labelled to state that it should be used only on the advice of a physician.

  • SOR/78-422, s. 4
  • SOR/2016-74, s. 15

 Every cyclamate sweetener shall be labelled to show

  • (a) its energy value expressed, in calories, per teaspoon, drop, tablet or other measure used in the directions for use and per 100 grams or 100 millilitres; and

  • (b) a list of all its ingredients and, in the case of cyclohexyl sulfamic acid or any of its salts or a carbohydrate, its quantity.

  • SOR/78-422, s. 4
  • SOR/2016-74, s. 16

PART GControlled Drugs

DIVISION 1General

Definitions

Marginal note:Definitions

 The following definitions apply in this Part.

Act

Act means the Controlled Drugs and Substances Act. (Loi)

advertisement

advertisement includes any representation by any means whatever for the purpose of promoting, directly or indirectly, the sale or other disposal of a controlled drug. (publicité)

competent authority

competent authority means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of controlled drugs into or from the country. (autorité compétente)

compound

compound includes a preparation. (composé)

controlled drug

controlled drug means

  • (a) a controlled substance set out in the schedule to this Part; or

  • (b) in respect of a midwife, nurse practitioner or podiatrist, a controlled substance set out in the schedule to this Part that the midwife, nurse practitioner or podiatrist may prescribe, possess or conduct an activity with, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations. (drogue contrôlée)

designated criminal offence

designated criminal offence means

  • (a) an offence involving the financing of terrorism against any of sections 83.02 to 83.04 of the Criminal Code;

  • (b) an offence involving fraud against any of sections 380 to 382 of the Criminal Code;

  • (c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code;

  • (d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; or

  • (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d). (infraction désignée en matière criminelle)

destroy

destroy, in respect of a controlled drug, means to alter or denature it to such an extent that its consumption is rendered impossible or improbable. (destruction)

hospital

hospital means a facility that is

  • (a) licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness; or

  • (b) owned or operated by the Government of Canada or the government of a province and that provides health services. (hôpital)

international obligation

international obligation means an obligation in respect of a controlled drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)

label

label has the same meaning as in section 2 of the Food and Drugs Act. (étiquette)

licensed dealer

licensed dealer means the holder of a licence issued under section G.02.007. (distributeur autorisé)

midwife

midwife has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (sage-femme)

nurse practitioner

nurse practitioner has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (infirmier praticien)

package

package includes anything in which a controlled drug is wholly or partly contained, placed or packed. (emballage)

pharmacist

pharmacist means a person who is entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province. (pharmacien)

podiatrist

podiatrist has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (podiatre)

preparation

preparation means a drug that contains a controlled drug and an active medicinal ingredient in a recognized therapeutic dose, other than a controlled drug. (préparation)

prescription

prescription means an authorization given by a practitioner that a stated amount of a controlled drug be dispensed for the person named in it or the animal identified in it (ordonnance)

qualified person in charge

qualified person in charge means the individual designated under subsection G.02.004(1). (responsable qualifié)

Security Directive

Security Directive means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website. (Directive en matière de sécurité)

senior person in charge

senior person in charge means the individual designated under section G.02.003. (responsable principal)

test kit

test kit means a kit

  • (a) that contains a controlled drug and a reagent system or buffering agent;

  • (b) that is used during the course of a chemical or analytical procedure to test for the presence or quantity of a controlled drug for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and

  • (c) the contents of which are not intended or likely to be consumed by, or administered to, a person or an animal. (nécessaire d’essai)

  • SOR/78-220, s. 1
  • SOR/85-550, s. 1
  • SOR/86-91, s. 1
  • SOR/90-261, s. 1(F)
  • SOR/92-386, s. 1
  • SOR/97-228, s. 7
  • SOR/97-515, s. 2
  • SOR/2003-135, s. 2
  • SOR/2004-238, s. 1
  • SOR/2012-230, s. 6
  • SOR/2018-147, s. 29
  • SOR/2019-171, s. 1
 

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